PHEDRE试验方案——关于法国镰状细胞病患者群体中氧气与一氧化二氮等摩尔混合物（EMONO）及镇痛药使用问题发生率的观察性研究。
PHEDRE trial protocol - observational study of the prevalence of problematic use of Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) and analgesics in the French sickle-cell disease population.
作者信息
Gérardin Marie, Couec Marie-Laure, Grall-Bronnec Marie, Feuillet Fanny, Wainstein Laura, Rousselet Morgane, Pinot Marie-Lyne, Perrouin Fanny, Bonnot Olivier, Drouineau Marie-Hélène, Jolliet Pascale, Victorri-Vigneau Caroline
机构信息
Clinical Pharmacology Department, Nantes University Hospital, Institut de Biologie, 9 quai Moncousu, 44093, Nantes Cedex 1, France.
EA 4275 SPHERE « bioStatistics, Pharmacoepidemiology and Human sciEnces REsearch, Faculties of Medicine and Pharmaceutical Sciences, Nantes University, Nantes, France.
出版信息
BMC Psychiatry. 2015 Nov 14;15:281. doi: 10.1186/s12888-015-0677-5.
BACKGROUND
The use of analgesics can lead to cases of drug abuse and dependence. It can also cause pseudo-addiction in patients suffering from pain. What is the actual situation in patients suffering from severe sickle-cell disease, exposed to acute pain during vaso-occlusive crises? Evaluation of the use of analgesics, on the basis of Diagnostic and Statistical Manual of Mental Disorders criteria for substance abuse and dependence, makes it possible to differentiate the symptoms occurring only in a context of pain, in the aim of managing the pain, and thus describing pseudo-addiction, from symptoms also occurring when there is no pain, and more in favour of true addiction. Currently there is no data available in France on this problem, and no studies have been carried out in children or adolescents with sickle-cell disease. The purpose of the study is to evaluate the prevalence of problematic use of equimolar mixture of oxygen and nitrous oxide and other analgesic drugs in a population of subjects with severe sickle-cell disease in France.
METHODS/DESIGN: PHEDRE (Pharmacodépendance Et DREpanocytose-drug dependence and sickle-cell disease) is an observational, descriptive and transversal study. Patients under the age of 26 with sickle-cell disease are included in the study by the doctors looking after them in sickle-cell disease centres. The patients are then contacted by a trained researcher for a telephone interview, including an evaluation of the Diagnostic and Statistical Manual of Mental Disorders criteria for abuse and dependence to equimolar mixture of oxygen and nitrous oxide and for each of the analgesic drugs taken by the patient. The data are also completed using the subject's medical record.
DISCUSSION
This study will make it possible to provide an initial quantitative and qualitative evaluation of problematic use of equimolar mixture of oxygen and nitrous oxide and analgesic drugs in the sickle-cell disease population. The results will be used firstly to provide additional data essential for monitoring the risk of overdose, abuse, dependence and misuse of these products, and to begin awareness-raising and to provide information for health care professionals, in order to significantly improve the management of sickle-cell disease-related pain.
TRIAL REGISTRATION
Clinical Trials.gov ID: NCT02580565 registered 16 October 2015 Unique Protocol ID: RC14_0344.
背景
使用镇痛药可能导致药物滥用和依赖情况。它还可能在疼痛患者中引发假性成瘾。对于患有严重镰状细胞病且在血管闭塞性危象期间经历急性疼痛的患者，实际情况如何？根据《精神疾病诊断与统计手册》中关于物质滥用和依赖的标准对镇痛药的使用进行评估，有助于区分仅在疼痛背景下为控制疼痛而出现的症状，即描述假性成瘾，与在无疼痛时也出现的、更倾向于真正成瘾的症状。目前在法国尚无关于此问题的数据，且尚未对患有镰状细胞病的儿童或青少年开展研究。本研究的目的是评估在法国患有严重镰状细胞病的人群中，氧气和一氧化二氮等摩尔混合物及其他镇痛药使用问题的发生率。
方法/设计：PHEDRE（药物依赖与镰状细胞病）是一项观察性、描述性横断面研究。26岁以下患有镰状细胞病的患者由镰状细胞病中心负责照料他们的医生纳入研究。然后由一名经过培训的研究人员联系患者进行电话访谈，包括根据《精神疾病诊断与统计手册》标准对氧气和一氧化二氮等摩尔混合物以及患者服用的每种镇痛药的滥用和依赖情况进行评估。数据还将通过受试者的病历进行补充。
讨论
本研究将能够对镰状细胞病患者群体中氧气和一氧化二氮等摩尔混合物及镇痛药使用问题进行初步的定量和定性评估。研究结果首先将用于提供监测这些产品过量使用、滥用、依赖和误用风险所需的额外数据，并开始开展提高认识活动，为医护人员提供信息，以显著改善与镰状细胞病相关疼痛的管理。
试验注册
ClinicalTrials.gov标识符：NCT02580565，于2015年10月注册 唯一方案标识符：RC14_0344。
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